what most of the food industry would
have considered RTE. Within the fresh
produce industry, for example, intact
fruits and vegetables were historically
considered not RTE because they are
raw agricultural products (RACs) that
need to be washed before consumption.

However, it’s increasingly recognized
that being an RAC and being RTE are
not mutually exclusive. The knowledge
that someone may eat an apple or pop a
cherry tomato in their
mouth without first
washing it places intact produce squarely
within the RTE definition. Claiming that
your product is not
RTE so that you don’t
have to worry about
environmental monitoring is not going to
fly.

So what should you do when you
realize that FDA may consider your
food RTE? Consider the potential for
postprocess contamination. It’s up to
each facility to evaluate the risk and
determine the extent to which Good
Manufacturing Practices (GMPs) help
keep food safety in order. Most notable
outbreaks and recalls related to environmental contamination occurred in situations where GMPs were not perfectly
implemented, so going back to basics
should be the first step.

If you determine that there is a concern about environmental pathogens
contaminating product that adherence
to GMPs might not fully address, then
couple a strong sanitation program
with aggressive monitoring for environmental pathogens for the best outcome.
Of course, facilities may choose to
verify the adequacy of sanitation using
ATP (adenosine triphosphate) checks,
aerobic plate counts and yeast and
mold counts, but these are insufficient
when it comes to postprocess pathogen
monitoring. On the other hand, there
is little point to conducting environmental monitoring when you know
that cleaning and sanitation are not
adequate.

Once you are confident in the clean-ing and sanitation program, refer toexisting industry (or FDA) guidance todevelop a plan. There are a few com-mon practices you should reevaluate:• Swabbing during pre-op, not produc-tion• Compositing• Trending and corrective actions

Swabbing during pre-op, not production

A practice I’ve
observed is that facilities tend to swab and
sponge after sanitation,

before product is run-ning. The advantageof this approach isthat if the tested areais a product contactsurface, it can beresanitized beforeproduction begins, sothat product is not implicated if a posi-tive result is obtained. However, thisapproach may not provide an accuratepicture of the environment. Assuming aharborage is hidden and difficult to ac-cess, it may be better to run the line fora while so that the bacteria have time towork their way into areas more likely tobe swabbed.

Compositing

Facilities should also think carefully
about the value of compositing (in
this case, combining separate samples
into a single sample). Some companies
composite samples taken within the
same zone; others may composite swabs
taken within close proximity of one another. If a positive is found, think about
how you will pinpoint the true positive.
The obvious approach is to swab the
sites individually. But if all follow-up
retesting results are negative, where did
that original positive come from? You
don’t know, and you’ve lost the opportunity to vector out and hunt down the
original source. Considerable thought
should be given to balancing resources
against the number of sites that should
be tested and determining the best overall approach.

Trending and corrective actions

The “seek and destroy” mantra,
which was greatly effective at virtually
eliminating postprocess contamination
with Lm in the RTE meat industry,
seems to be permeating the entire food
industry. Word seems to have spread
that finding an occasional positive is a
good thing because it shows diligence
and an aggressive approach. Naturally,
you need to trend positive results to
show that you do maintain control over
the production environment and that
positives are not a symptom of a persistent problem. If they are, FDA may pull
your facility registration.1

However, now that the industry is really looking for positives, the stumbling
block seems to be what to do when
a positive is found. Do you simply
reclean, sanitize, retest and move on?
I’ve seen this approach in some environmental monitoring plans. The flaw is
that you can’t be certain if the positive
is due to a transient organism that just
happened to be passing through the facility, or if you swabbed a point of harborage where the organism had taken
residence or if you found an organism
that had traveled from a harborage site.

If the positive was truly a transient
organism, then cleaning and sanitizing
should eliminate it, and retesting should
be negative. If you found the harborage
and truly eliminate it through cleaning
and sanitizing, then retesting should be
negative. However, what if the positive
was due to an organism that had been
part of a larger community and broke
free? Retesting after cleaning and sanitizing should yield a negative, but you
might have a false sense of security because you didn’t actually eliminate the
root of the problem. This is why vectoring out and sampling locations that are
close to the initial positive should be
done. It’s also why plotting positives
on a physical map may also reveal that
seemingly one-off positive results are
actually related to one another.

In reviewing environmental monitoring programs for food manufacturing
facilities, a common weakness is the
investigation into the root cause of the